What side effects are associated with this type of intervention?

Common treatments for mouth sores include topical anesthetics, antiseptic mouthwashes, corticosteroids, and photobiomodulation therapy (PBMT). PBMT, which uses light to reduce inflammation and promote healing, is generally well-tolerated with minimal side effects. Some patients may experience mild discomfort or a warming sensation during the treatment. Other treatments, such as topical anesthetics, can cause temporary numbness or a tingling sensation, while antiseptic mouthwashes may lead to a burning sensation or altered taste. Corticosteroids can have side effects like oral thrush or systemic effects if used long-term.

What prior FDA approvals exist?

The FDA has approved several treatments for mouth sores, particularly those caused by conditions like oral mucositis. One notable treatment is low-level laser therapy (LLLT), which uses light to reduce inflammation and promote healing, similar to PBMT. Additionally, the FDA has approved drugs like palifermin (Kepivance), which is a keratinocyte growth factor that helps to reduce the incidence and duration of severe oral mucositis in patients undergoing hematopoietic stem cell transplantation. These treatments aim to alleviate pain and accelerate the healing process in patients suffering from mouth sores.

What other types of research exist?

Promising novel alternatives to Intraoral Photobiomodulation Therapy (PBMT) for treating mouth sores include: 1) Low-Level Laser Therapy (LLLT), which has shown benefits in healing and symptom relief in various conditions. 2) Autologous Platelet Concentrates (APC), which have been used to enhance healing in oral surgery and may prevent complications like osteonecrosis. 3) Hyperbaric Oxygen Therapy (HBO), which has demonstrated some improvement in wound healing and pain management in related conditions. These alternatives offer different mechanisms to reduce inflammation and promote healing.

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Photobiomodulation

Photobiomodulation Therapy for Mouth Sores from Bone Marrow Transplant

N/A

Recruiting

Led By Kentaro Ikeda, DDS, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Planned to undergo myeloablative allogeneic HCT using FluBu4 conditioning and Tac-Mtx GVHD prophylaxis

Must not have

Participants who have a history of radiation therapy to the head and neck

Participants who are planned to receive palifermin for OM prevention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a light therapy device called THOR LX2.3 with LED Lollipop to prevent painful mouth sores in patients undergoing a specific type of stem cell transplant. The therapy uses light to reduce inflammation and speed up healing inside the mouth. About 20 patients will receive this treatment during their chemotherapy and for a period afterward.

Who is the study for?

This trial is for adults over 18 who are about to receive a bone marrow transplant and have agreed to the study. It's not for those who've had photobiomodulation therapy recently, radiation on their head or neck, issues with light sensitivity, or will be treated with palifermin.

What is being tested?

The trial tests if a special LED device called THOR LX2.3 can prevent mouth sores in patients getting intense chemotherapy before a bone marrow transplant. Participants will use this LED Lollipop daily during treatment.

What are the potential side effects?

Potential side effects of using the LED Lollipop may include discomfort in the mouth or changes in taste sensation, but since it's non-invasive, serious side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for a specific bone marrow transplant with FluBu4 and Tac-Mtx.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy to my head or neck.

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I am scheduled to receive palifermin for mouth sore prevention.

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I have a history of reacting badly to sunlight.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Duration of severe Oral Mucositis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: INTRAORAL PBMT IN PATIENTS UNDERGOING alloHCTExperimental Treatment1 Intervention

The research study procedures include: screening for eligibility and study treatment including daily PBMT and clinical evaluations. Participants will receive the study treatment daily from the start of conditioning chemotherapy to day +20, or discharge (if you are able to be discharged from the hospital prior to day +20), whichever occurs first -THOR LX2.3 with LED Lollipop

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for mouth sores, such as intraoral photobiomodulation therapy (PBMT), work by using specific wavelengths of light to penetrate tissues, which helps reduce inflammation and promote healing. This light stimulation reduces oxidative stress, enhances cellular energy production, and modulates inflammatory responses, leading to faster tissue repair and pain relief. For mouth sore patients, these mechanisms are important as they offer a non-invasive option to manage symptoms effectively and improve healing outcomes.

Simultaneous red and infrared light-emitting diodes reduced pain in individuals with temporomandibular disorder: a randomized, controlled, double-blind, clinical trial.